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Tech Alert: Outcomes of the Permissible ingredients consultation: Valerian, Chelidonium, Chaparral

01 Dec 2022 11:25 AM | Anonymous member (Administrator)

The TGA has published outcomes of the consultation on proposed low0negligible risk changes to the Permissible Ingredients Determination, which occurred in August - September 2022.

The outcome of the consultation is largely aligned with CMA’s submission to the consultation, which advocated for a number of changes to reduce the level of impact of the proposal. These changes relate to warning statements for:

 - Valerian

 - Chelidonium

 - Chaparral

The final changes will commence on 1 March 2023, after which new (or newly ‘grouped’) medicines that are released for supply are generally expected to be compliant with new requirements.

For existing medicines, a one-year transition period will be instated to allow sponsors to ensure product compliance, ending on 1 March 2024

Please read today’s Tech Alert for more information and details.

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